NCT04929366

Brief Summary

Hemodialysis (HD) triggers recurrent and cumulative ischemic insults to the brain and the heart. Cooled dialysate may have a protective effect on major organs and improve hemodynamic tolerability of dialysis. The aim of the study was to compare HD with cooled dialysate with routine dialysis in terms of hemodynamic stability and levels of high sensitivity Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

2.9 years

First QC Date

June 3, 2021

Last Update Submit

June 9, 2021

Conditions

Renal Insufficiency, Chronic

Keywords

End-Stage Kidney DiseaseHypothermic hemodialysisCardiovascular eventsTroponin TBrain natriuretic peptide

Outcome Measures

Primary Outcomes (2)

  • Comparison of hypothermic dialysis with routine dialysis in terms of hemodynamic stability

    For each patient, four blood pressure measurements including systolic blood pressure, diastolic blood pressure and mean arterial pressure were performed at the beginning, after 2 hours, after 3 hours after 4 hours (end of hemodialysis).

    one year

  • Assessments of the levels of high sensitivite Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis

    Blood samples were collected at the beginning of the dialysis session, and a second sample was taken in the last 5 minutes of hemodialysis in order to evaluate the relationship between hemodialysis with cooled dialysate (hypothermic dialysis) and the myocardial markers hs-TnI and NTproBNP and to monitor hypothermic hemodiaysis treatment response.

    6 months

Study Arms (2)

End-stage kidney patients treated in the dialysis unit group 1

EXPERIMENTAL
Procedure: Hypothermic dialysis followed with routine dialysis

End-stage kidney patients treated in the dialysis unit group 2

EXPERIMENTAL
Procedure: Routine dialysis followed with hypothermic dialysis

Interventions

Hypothermic dialysis followed with routine dialysisPROCEDURE

Hypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate)

End-stage kidney patients treated in the dialysis unit group 1
Routine dialysis followed with hypothermic dialysisPROCEDURE

Routine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate)

End-stage kidney patients treated in the dialysis unit group 2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with renal insufficiency treated with dialysis for a period of at least three months.

You may not qualify if:

  • Patients who experienced myocardial infarction during the three months prior to the start of the study
  • Patients who underwent vascular surgery during the last month
  • Patients who experienced chest pain at rest during the last week before the start of the trial - Patients who had to discontinue dialysis prematurely due to hemodynamic instability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Department, Ziv Medical Center

Safed, 13100, Israel

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Younes Bathish, MD

    Ziv Medical Centre, Safed, Israel / Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Internal Medicine A

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 18, 2021

Study Start

December 18, 2017

Primary Completion

November 16, 2020

Study Completion

November 16, 2020

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

IL(1)